510(k) · Cleared
ClearedML830TP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlight Corporation of America · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 3, 2008 as substantially equivalent to K070516 (Powermedic Aps, 2007) and 2 other predicates after a 197-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 3, 2008
- Review
- 197 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010175 (2002). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| −2 | K030692 | Power Laser 90 | Andi Electromedical Aps | 2003 | — |
| −1 | K070516 | Powerlaser | Powermedic Aps | 2007 | — |
| 0 (this device) | K080786 | ML830TP | Microlight Corporation of America | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ILY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070516 | PowerlaserSummary page 1…urrently in commercial distribution such as the Powerlaser by Powermedic APS which is the subject of a clearance letter from the Agency under 510(k) number K070516, which itself was predicated on the PowerLaser 90, the subject of K030692. In addition, or in the alternative, the ML830®T… | 2007 |
| * | K030692 | Power Laser 90Summary page 1…which is the subject of a clearance letter from the Agency under 510(k) number K070516, which itself was predicated on the PowerLaser 90, the subject of K030692. In addition, or in the alternative, the ML830®TP is substantially equivalent to the Thor VR Single Diode Laser Treatment… | 2003 |
| * | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeSummary page 1…30®TP is substantially equivalent to the Thor VR Single Diode Laser Treatment Probe which is the subject of a clearance letter from the Agency under 510(k) K070024.. These three predicate devices were cleared by the Agency for introduction into interstate commerce by means of t… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K070516.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
MicroLight Corporation of America's ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080786: ML830TP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080786
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026